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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus Ureteroreno videoscope

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 Class 2 Device Recall Olympus Ureteroreno videoscopesee related information
Date Initiated by FirmMarch 25, 2022
Create DateMay 19, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1116-2022
Recall Event ID 90063
510(K)NumberK172246 
Product Classification Endoscope, accessories, narrow band spectrum - Product Code NWB
ProductOlympus Uretero-reno videoscope, Model No. URF-V2
Code Information 1 unit, serial number 2825505F UDI 04953170343582
FEI Number 2429304
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information ContactCynthia Ow
484-896-5000
Manufacturer Reason
for Recall		The bending section of the URF-V2 may crack, resulting in an abnormal shape or abnormal angulation of the bending section.
FDA Determined
Cause 2		Process change control
ActionOn March 25, 2022, the firm contacted the affected consignee to inform them that certain manufacturing changes by a supplier led to the possibility that a part within the bending section may crack. Olympus repaired the affected URF-V2 unit free of charge.
Quantity in Commerce1
DistributionUS Nationwide distribution in the state of AZ.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NWB
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